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Identification of Correlations Between Reaction to Biotine and Autoimmune Diseases

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified August 2013 by Ziv Hospital
Sponsor:
Information provided by (Responsible Party):
Assy Nimer, Ziv Hospital
ClinicalTrials.gov Identifier:
NCT01934764
First received: August 29, 2013
Last updated: September 3, 2013
Last verified: August 2013
  Purpose

Working hypothesis and aims: Biotin is conjugated covalently to several proteins and use as a co-factor. Conjugation of biotin to non-targeted, unspecific proteins (e.g. immunoglobulins) leads to the breakage of the immune tolerance and to the formation of anti-biotin antibodies. Anti-biotin antibodies will be found in correlation with the progression and the present of autoimmune disease. In this research the correlation between immune response against biotin and the formations of autoimmune disease, will be studied:

A. Assessment of the possibility that biotin elicit immune response involved in the developmental stage of the autoimmune disease.

B. Assessment of the possibility that anti-biotin antibodies indicate the developmental stage of the autoimmune disease and therefore can serve as an disease early stage marker.

Methods: A. Patient recruitment. Gathering participant's medical record and blood samples. B. Records of clinical and biochemical measures. C. Serum of all patient will be tested for the correlation between biotin level, biotin bound to antibodies and anti-biotin antibodies to liver functions tests. D. Controlled test for repeatedly injected mice with biotinilated self-antibodies. Level of anti-biotin will be tested and their influence on the mouse. E. Determination of the correlation between biotinilated antibodies or anti-biotin antibodies to disease eruption or severance and autoimmune disease.

Expected results :Serum biotin-protein levels and Anti biotin antibodies levels are increased in patients with active autoimmune liver diseases.

Importance: The proof of connection between biotin-carrying immunoglobulins, anti biotin antibodies and autoimmune diseases will open new research direction of possible factors that cause to autoimmune disease.

Probable implications to Medicine: Identification of correlations between reaction to biotine and autoimmune diseases will enable their usage as biomarkers for autoimmune diseases, severity of the disease and personalization of treatment.


Condition
Autoimmune Disease

Study Type: Observational
Study Design: Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by Ziv Hospital:

Primary Outcome Measures:
  • Biotin level Test [ Time Frame: Baseline ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 60
Study Start Date: September 2013
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
autoimmune disease

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

People with autoimmune disease

Criteria

Inclusion Criteria:

  • Freely given informed consent
  • Autoimmune disease

Exclusion Criteria:

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01934764

Contacts
Contact: Nimer Assy, MD +972-4-6828442 assy.n@ziv.health.gov.il

Locations
Israel
Ziv Medical Center Not yet recruiting
Safed, Israel, 13100
Contact: Nimer Assy, MD    +972-4-6826442    assy.n@ziv.health.gov.il   
Sponsors and Collaborators
Ziv Hospital
  More Information

No publications provided

Responsible Party: Assy Nimer, MD, Ziv Hospital
ClinicalTrials.gov Identifier: NCT01934764     History of Changes
Other Study ID Numbers: 0027-13-ziv
Study First Received: August 29, 2013
Last Updated: September 3, 2013
Health Authority: Israel: Ministry of Health

Additional relevant MeSH terms:
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on November 27, 2014